Aurobindo Pharma receives USFDA Approval for
Risedronate Sodium Tablets.
Aurobindo Pharma Limited announced that the company has received final approval from
the US Food & Drug Administration (USFDA) to manufacture and market Risedronate Sodium TabletsUSP, 5 mg, 30 mg and 35 mg (ANDA 200296). This approval is an extension of tentative approval received on 10th October 2012.
This product is ready for launch.
The approved ANDA is bioequivalent and therapeutically equivalent to the reference listed drug product
(RLD) ACTONEL® Tablets of Warner Chilcott Co., LLC Risedronate Sodium Tablets are used in the treatment of Osteoporosis.
The approved product has an estimated market size of US$113 million for the twelve months ending October 2015 according to IMS.
Aurobindo now has a total of 219 ANDA approvals (191 Final approvals including 10 from Aurolife Pharma LLC and 28 Tentative approvals) from USFDA.
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